This invention is in the field of oral pharmaceuticals, and especially in pain management.
Magnesium is the seventh most plentiful element in the human body and the most common intracellular divalent cation. A cofactor in hundreds of enzymatic processes, including all enzymes utilizing adenosine triphosphate, magnesium""s multiple physiologic effects have been recognized for decades. Clinical studies have suggested that magnesium, as a pharmacologic agent, may be beneficial in many disorders including asthma, cardiac arrhythmias, eclampsia, headaches including migraines, hypertension, mania, mitral valve prolapse, muscle cramps, pain syndromes, various menstrual symptoms, seizures, tetanus, and vasospastic disorders. However, the results from various studies have not been unequivocal. These varied results may be due in part to the limited pharmacologic effects of usual oral dosages of 250-500 mg/day, doses that hardly differ from the recommended daily allowances for magnesium of 350 mg/day for women and 420 mg/day for men. The use of higher oral doses has typically been precluded because of magnesium""s tendency to provoke diarrhea in many patients when administered orally. For example, in one study a dosage of 250 mg two times daily of magnesium administered orally produced adverse effects in 45.7% of subjects. Yet oral dosing is without question the administration route of choice. Intravenous drug administration requires that the patient be in a hospital or clinic. Where the condition being treated is chronic, this is impractical. Oral administration at pharmacologic doses is key to treating chronic conditions. However oral dosing at pharmacologic levels has heretofore been ineffective due to the inability of patients to tolerate such a regimen.
The inventors have developed a method for successfully introducing high doses of oral magnesium without the tolerance problems previously associated with high oral dosing. This high oral dose magnesium is particularly useful in the treatment of intractable erythromelalgia (EM), neuropathic conditions, and other related neurovascular disorders, and has produced startling results in the management of pain and other symptoms associated with these diseases.
A method of treating patients, particularly for pain associated with diseases including erythromelalgia, chronic regional pain syndrome, and reflex sympathetic dystrophy, involves orally administering high doses of magnesium. The magnesium is introduced through several daily administrations, totaling approximately 2-12 times the RDA for magnesium (600 mg to 5 gm elemental magnesium). These higher levels are achieved through increasing daily dosage amounts gradually in response to patient tolerance and using a more well-tolerated form of magnesium preferably a magnesium solution. Total magnesium intake is divided over several doses per day and taken with copious amounts of water.
A method for treating a patient with magnesium supplementation comprising:
introducing said patient to a treatment regimen wherein orally administered magnesium dosage levels increase gradually over time from about 250 to 500 mg elemental magnesium/day to between about 600 mg and about 5000 mg/day elemental magnesium, wherein (i) each orally administered daily dosage amount is (a) in extended release form and/or (b) divided into smaller doses and orally administered several times per day, (ii) the orally administered daily dosage amount is gradually increased over time and in association with patient""s increased tolerance to the increased dosage, and (iii) the administered magnesium is in a solid form or a solution; and
maintaining a well-tolerated high-level dosage of orally administered magnesium until therapeutically effective magnesium supplementation is obtained.